Trial website

Contact information

Type

Primary contact

ORCID ID

Contact details

Edinburgh Research Centre Western General Hospital Crewe Road South Edinburgh EH4 2XR United Kingdom

Additional identifiers

EudraCT number

2004-000066-13

ClinicalTrials.gov number

NCT00301925

Protocol/serial number

N/A

Study information

Scientific title

Trial of Accelerated Adjuvant Chemotherapy with Capecitabine in Early Breast Cancer

Acronym

TACT2

Study hypothesis

A randomised, phase III clinical trial with a 2 x 2 factorial design addressing two hypotheses:1. That accelerating Epirubicin will improve the efficacy of the sequential schedules (based originally on the NEAT epirubicin/CMF schedule).2. That the substitution of CMF by Capecitabine will not be detrimental to patient outcome but will offer advantages in Quality of Life and/or toxicity.

On 19/11/2008 the overall trial end date was changed from 15/10/2008 to 05/12/2008.Please note as of 28/09/2011 this trial is closed to recruitment with ongoing follow-up.

Ethics approval

Protocol TACT2: Version 1d approved on the 23/09/2005, UK Ethics Committee MREC ref: 04/MRE00/88. Version 3 approved on the 13/05/2008. Current protocol, version 5 approved July 2009.

Overall trial start date

15/10/2005

Overall trial end date

01/09/2024

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with early breast cancer for whom treatment with anthracycline chemotherapy is indicated.

1. Histological diagnosis of invasive breast carcinoma2. Completely resected disease with negative surgical margins (apart from deep margin if full thickness resection).3. Early stage disease (T0-3 N0-2 M0)with no evidence of distant metastases on routine staging4. Definite indication for adjuvant chemotherapy5. ECOG status 0 or 16. Aged over 18 years (no upper age limit)7. Fit to receive any of the trial chemotherapy regimens, with adequate bone marrow, hepatic, and renal function ie:7.1 Hb > 9g/dL; WBC > 3 ´ 109/L; platelets > 100 x 109/L 7.2 Bilirubin within normal range (unless known Gilberts disease)7.3 AST/ALT = 1.5 x Upper limit of normal (ULN)7.4 Albumen within normal range 7.5 Creatinine = 1.5 x ULN and calculated creatinine clearance using Cockroft-Gault formula > 50 ml/min 7.6 No active, uncontrolled infection8. Signed TACT2 trial consent form9. Randomisation within 8 weeks of surgery, but ideally within 1 month 10. No previous chemotherapy, hormonal therapy or radiotherapy for the treatment of pre-invasive or invasive cancer except:10.1 Previous radiotherapy for basal cell carcinoma 10.2 Previous pre-operative endocrine therapy provided that there was no evidence of progression during this therapy, that it was for less than 6 weeks in duration, and was stopped at least one month prior to trial entry11. No previous malignancy except in the case of DCIS, or basal cell carcinoma or cervical carcinoma in situ, or where the patient has been disease-free for 10 years, and where treatment consisted solely of resection.12. Non-pregnant and non-lactating, with no intention of pregnancy during chemotherapy, and prepared to adopt adequate contraceptive measures if pre-menopausal and sexually active13. No concomitant medical, psychiatric or geographic problems that might prevent completion of treatment or follow-up

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

4400 patients (both male and female)

Participant exclusion criteria

1. Only cytological proof of malignancy2. No evidence of invasive breast cancer3. Previous invasive breast cancer or bilateral breast cancer (surgically treated DCIS or LCIS is allowed) 4. Locally advanced breast cancer (T4 and/or N3 disease)5. Patients who have had breast conserving surgery in whom there is a contra-indication for, or refusal of post-operative radiotherapy 6. Patients with positive surgical margins unless either:6.1 Deep surgical margin involvement following full thickness resection6.2 Non-invasive cancer at surgical margins and a decision to perform mastectomy on completion of chemotherapy has already been made7. Patients not able or willing to give informed consent8. Patients known not to be available for a minimum of 5 years' follow-up9. Patients with known serious viral infection such as active Hepatitis B, Hepatitis C or HIV10. Patients with significant cardiac disease, such as impaired left ventricular function or active angina (requiring regular anti-anginal medication and/or resulting in restricted physical activity)11. Patients with a history of significant renal impairment or disease12. Simultaneous participation in the active intervention phase of another treatment trial13. Being approached and recruited into the active intervention phase of another treatment trial two months before or after recruitment into TACT2